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Target Organs and Levels of Evidence for TR-390

Toxicology and Carcinogenesis Studies of 3,3'-Dimethylbenzidine Dihydrochloride (CASRN 612-82-8) in F344/N Rats (Drinking Water Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
3,3'-Dimethylbenzidine dihydrochloride
612-82-8		 04/25/1990 Dosed-Water
RATS ONLY: 0,30,70,150 PPM (70,45,75,70 PER GROUP RESPECTIVELY)		 Hazleton, Vienna

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Skin: BASAL CELL ADENOMA 0/60 10/45 52/75 29/60 OR BASAL CELL CARCINOMA 0/60 1/45 4/75 2/60 COMBINED 0/60 11/45 54/75 30/60; SEBACEOUS GLAND ADENOMA 0/60 0/45 7/75 5/60; KERATOACANTHOMA 1/60 1/45 8/75 5/60; SQUAMOUS CELL PAPILLOMA 0/60 0/45 8/75 15/60 OR SQUAMOUS CELL CARCINOMA 0/60 2/45 10/75 13/60 COMBINED 0/60 2/45 17/75 27/60
  • Zymbal Gland: ADENOMA 1/60 1/45 13/75 16/60 OR CARCINOMA 0/60 2/45 21/75 23/60 COMBINED 1/60 3/45 32/75 36/60
  • Preputial Gland: ADENOMA 2/60 4/45 4/75 8/60 OR CARCINOMA 0/60 0/45 2/75 1/60 COMBINED 2/60 4/45 6/75 9/60
  • Liver: NEOPLASTIC NODULE 0/60 0/45 29/75 26/60 OR CARCINOMA 0/60 0/45 12/75 12/60 COMBINED 0/60 0/45 35/75 33/60
  • Oral Cavity: SQUAMOUS CELL PAPILLOMA 0/60 0/45 3/75 2/60 OR SQUAMOUS CELL CARCINOMA 0/60 0/45 1/75 3/60 COMBINED 0/60 0/45 4/75 5/60
  • Large Intestines: ADENOMATOUS POLYP 0/60 0/45 7/75 10/60 OR ADENOCARCINOMA 0/60 0/45 3/75 15/60 COMBINED 0/60 0/45 10/75 23/75
  • Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 1/60 0/45 7/75 6/60 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 0/60 0/45 1/75 0/60 COMBINED 1/60 0/45 8/75 6/60
  • Mesothelium (Abdominal Cavity/Tunica Vaginalis): MESOTHELIOMA 0/60 0/45 3/75 4/60
May Have Been Related
  • Brain: GLIOMA 0/60 0/45 1/75 1/60; MENINGIOMA 0/60 0/45 0/75 1/60; MENINGEAL SARCOMA 0/60 0/45 1/75 0/60
Non-Neoplastic Lesions
  • PREPUTIAL GLAND: HYPERPLASIA
  • LIVER: CYSTIC DEGENERATION; FOCAL CELLULAR ALTERATIONS
  • LUNG: HYPERPLASIA
  • ZYMBAL GLAND: HYPERPLASIA
Female Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Skin: BASAL CELL ADENOMA 0/60 3/45 5/75 5/60 OR BASAL CELL CARCINOMA 0/60 0/45 5/75 4/60 COMBINED 0/60 3/45 10/75 9/60; SQUAMOUS CELL PAPILLOMA 0/60 1/45 6/75 5/60 OR SQUAMOUS CELL CARCINOMA 0/60 2/45 4/75 7/60 COMBINED 0/60 3/45 9/75 12/60
  • Zymbal Gland: ADENOMA 0/60 4/45 11/75 12/60 OR CARCINOMA 0/60 2/45 22/75 35/60 COMBINED 0/57 6/45 32/75 42/60
  • Clitoral Gland: ADENOMA 0/60 9/45 32/75 17/59 OR CARCINOMA 0/60 5/45 11/75 18/59 COMBINED 0/60 14/45 42/75 32/59
  • Liver: NEOPLASTIC NODULE 0/60 0/45 7/74 3/60 OR CARCINOMA 0/60 0/45 1/74 1/60 COMBINED 0/60 0/45 7/74 4/60
  • Oral Cavity: SQUAMOUS CELL PAPILLOMA 0/60 3/45 7/75 9/60 OR SQUAMOUS CELL CARCINOMA 0/60 1/45 2/75 4/60 COMBINED 0/60 3/45 9/75 13/60
  • Large Intestines: ADENOMATOUS POLYP 0/60 2/45 7/75 4/60 OR ADENOCARCINOMA 0/60 0/45 3/75 6/60 COMBINED 0/60 2/45 10/75 9/60
  • Mammary Gland: ADENOCARCINOMA 0/60 1/45 3/75 6/60
  • Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 1/60 1/45 3/74 3/60 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 0/60 0/45 0/74 1/60 COMBINED 1/60 1/45 3/74 4/60
May Have Been Related
  • Brain: ASTROCYTOMA 0/60 1/45 1/75 0/60; GLIOMA 0/60 0/45 1/75 1/60; MENINGIOMA 0/60 1/45 0/75 0/60
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 1/60 3/45 6/75 4/60
Non-Neoplastic Lesions
  • CLITORAL GLAND: HYPERPLASIA
  • LIVER: CYSTIC DEGENERATION; FOCAL CELLULAR ALTERATIONS
  • LUNG: HYPERPLASIA
  • ZYMBAL GLAND: HYPERPLASIA